AccessGUDID - DEVICE: CapSure Cloud (B377GMR1602008X0)

GUDID

Device Identifier (DI) Information

Brand Name: CapSure Cloud
Version or Model: 2.1.x
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Globalmed Holdings, LLC

Primary DI Number: B377GMR1602008X0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 08, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 103201849 *Terms of Use

Device Description: CapSure Cloud is a secure cloud-based web application for medical image archiving and management.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60724	Multidisciplinary medical image management software	A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130624	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0142a98d-d670-4d03-9d16-98b62bec01a1
Public Version Date: December 24, 2024
Public Version Number: 7
DI Record Publish Date: September 12, 2016